MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP364H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mjm737 number, and no non-conformances were identified.Investigation summary: there was no sample received for analysis.Only pictures of the sample were received for analysis.Upon visual inspection of the picture, a used samples of product code vcp364 lot# mjm73 with the needle detached could be observed, however, no conclusion could be reach on how this happen as the samples were not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The following additional information was obtained: confirm the lot for the 2nd device involved, is it the same as reported? mjm737.Was procedure completed successfully? and how? the procedure was completed successfully by opening another new pack of suture to continue the wound closure.Any patient consequences? no.Any sample available to be returned for evaluation? no defected product were returned as the nurses disposed all.Note: events reported via medwatch 2210968-2019-82720.
Event or Problem Description
It was reported that the patient underwent caesarean section on (b)(6) 2019 and suture was used.During the procedure, the thread detached from the needle when repairing the uterus.The procedure was completed successfully by opening another new pack of suture to continue the wound closure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8697299
• Report Number: 2210968-2019-82719
• Device Sequence Number: 11404771
• Product Code: GAM
• UDI-Device Identifier: 10705031052772
• UDI-Public: 10705031052772
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: VCP364H
• Device Lot Number: MJM737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1